Archive for the ‘Treatment’ Category

Another Whistleblower Promptly Fired For Showing Pfizer Falsified Data. Got Science? Are You Sure?

**UPDATE Feb. 18, 2022**

Here is the case filing of the lawsuit against Pfizer:  https://www.documentcloud.org/documents/21206071-brook-jackson-lawsuit

Case 1:21-cv-00008-MJT Filed 01/08/21

Core allegations:

Making or Using False Records or Statements to Cause Claims to be Paid (31 U.S.C. § 3729(a)(1)(B)) 284.

  1. “From 2020 to the present, Defendants knowingly made, used, or caused to be made or used, false records or statements that were material to false and/or fraudulent claims paid or approved by the United States DoD. These false records or statements include the clinical trial protocol Pfizer submitted to the United States and the falsified source documents and data behind Defendants’ trial results and EUA application.

  2. By creating and carrying out their fraudulent schemes, Defendants knowingly and repeatedly violated Section 3729(a)(1)(B) of the False Claims Act. 286. Defendants’ false records were material to Pfizer’s claims for payment for the vaccine at issue. The United States DoD would not have paid Pfizer if it knew that the clinical trial protocol was not complied with by Defendants, because the protocol violations call the integrity and validity of both the entire clinical trial and Pfizer’s EUA into question.

  3. Defendants’ false records also went to the very essence of the bargain the United States contracted for. DoD contracted to purchase vaccines found effective by a valid clinical trial conducted according to the protocol submitted by Pfizer. The integrity of the entire clinical trial was compromised by the trial protocol violations, false source documents, and the false data that resulted, which calls the vaccine’s EUA into question. Had the United States DoD known of Defendants’ false records, it would not have paid Pfizer. 288. Defendants’ use, or causation of use, of material false records was a foreseeable factor in the United States DoD’s loss and a consequence of Defendants’ schemes. By virtue of Defendants’ actions, the United States DoD has suffered actual damages and is entitled to recover treble damages plus a civil monetary penalty for each false and/or fraudulent claim.”

    Access: Case 1:21-cv-00008-MJT Filed 01/08/21

https://www.bmj.com/content/375/bmj.n2635.full

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

 
Paul D Thacker, investigative journalist
Author affiliations
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated. (See link for article)

Important excerpt:

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Speaking off the record, other employees confirmed that the fired employee’s concerns were valid:
  • “Everything that you complained about was spot on.”
  • “I don’t think it was clean data. It’s a crazy mess.”
  • “I’ve never had to do what they were asking me to do, ever, It just seemed like something a little different from normal—the things that were allowed and expected.”
  • One employee with over 4-dozen clinical trials under her belt said she had never experienced such a “helter skelter” work environment.
  • Ventavia lacked enough employees to test trial participants who reported COVID-like symptoms, which is important because symptomatic COVID was the trial’s primary endpoint.  An FDA review showed that swabs were not taken from 477 people with suspected COVID.

____________________

For more on Pfizer’s corruption:

https://live.childrenshealthdefense.org/shows/doctors-and-scientists-with-brian-hooker-phd  Video Here from Oct. 28, 2021

Live Every Thursday at 9:00a.m. PT, 11:00a.m. CT, 12:00p.m. ET

Got Science? Are you sure?

‘Doctors And Scientists’ With Brian Hooker, PHD.

Dr. Brian Hooker invites some of the leading voices in science and medicine to break down the studies and weigh in on the controversies so the rest of us have an opportunity to understand the science that drives public health policy and medical progress.

See previous episodes within link as well.

For more:

Category:

Activism, research, Treatment, vaccines, Viruses

“We See Clotting – NOT From Virus, but From Spike From ‘Vaccine’ Itself” & CDC Finally Weighs in On Natural Immunity

https://americasfrontlinedoctors.org/2/frontlinenews/we-see-clotting-not-from-virus-but-from-spike-from-vaccine-itself-aflds-medical-director-dr-ryan-cole/  Video Here (Approx. 1 Min)

‘We see clotting – not from virus, but from spike from vaccine itself’: AFLDS Medical Director Dr Ryan Cole

October 20, 2021

It doesn’t get much clearer than this.

These are not vaccines but clot shots.

__________________

https://www.washingtonpost.com/health/2021/11/01/what-works-better-vaccines-or-natural-immunity/

CDC finds immunity from vaccines is more consistent than from infection, but both last at least six months

Naturally acquired immunity is at the center of a political fight over President Biden’s vaccine mandates.

It’s a question that scientists have been trying to answer since the start of the pandemic, one that is central to the rancorous political debates over coronavirus vaccine policies: How much immunity does someone have after recovering from a coronavirus infection, and how does it compare with immunity provided by vaccination?

The Centers for Disease Control and Prevention has weighed in for the first time in a detailed science report released with little fanfare Friday evening. Reviewing scores of research studies and its own unpublished data, the agency found that both infection-induced and vaccine-induced immunity are durable for at least six months — but that vaccines are more consistent in their protection and offer a huge boost in antibodies for people previously infected. (See link for article)

_________________

**Comment**

Did you honestly believe the CDC would ever admit in 1,000 years that natural immunity is broader, more robust, and more effective than their dangerous, experimental, ineffective, unneeded lucrative shots (that aren’t vaccines), and that history and 15 studies clearly demonstrate?  Even a former CDC director points out the complete bias against natural immunity by stating that the FDA, without presenting any data, issued a public safety statement:

“while SARS-CoV-2 antibody tests play an important role in identifying people who have been exposed to the SARS-CoV-2 virus and may have developed an adaptive immune response, antibody tests should not be used to determine immunity or protection against COVID-19.”

Huh?

So it’s fine to use inaccurate tests to inflate COVID cases and deaths, but it’s not fine to use them to prove immunity. It’s also fine to change testing perimeters for the “vaccinated,” to make it appear they are not getting infected with COVID, when “breakthough” infections are common due to vulnerability to variants.  The“vaxxed” are being damaged from the injections, and even die from COVID. People are also dying due to the ineffective “Fauci protocol,”with some stating that “hospitals are modern day killing fields.” Despite Fauci are fed up with his filibustering.

Our corrupt public health ‘authorities’ happily spend your tax-dollars on grotesque Frankenstein, and dangerous research while continuing to make up science, bully dissenters, move goal-posts, change perimeters, and definitions, and lie with statistics without any oversight, to continue their narrative.

Remember, NIH developed the spike protein, which goes systemic in the body, crosses the blood, brain barrier, and has been determined to be a dangerous toxin. Also, remember our government is a vaccine manufacturer, completely in bed with Big Pharma.  It is also worth repeating that the U.S. federal government partially owns an mRNA COVID-19 “vaccine” and soon before their rollout the U.S. federal government ensured COVID-19 mRNA vaccines would be legal by changing the definition of vaccines to include mRNA technology.  This change occurred just weeks before the first “cases” broke out in the U.S. Mandates would have been much harder to impose without this change.  Coincidence?

Epidemiologists estimate over 160 million people worldwide have recovered from COVID-19. Those who have recovered have an astonishingly low frequency of repeat infection, disease, or death. Immunity from prior infection protects – plain and simple. Regarding the injections; however, one expert states:

It’s worrisome that vaccination appears to deplete neutralizing Abs against the Spike protein gained by infection. It’s puzzling that vaccination appears also to deplete neutralizing Abs against the RBD (receptor-binding-domain) SARS-CoV-2 protein because the vaccines do not target that protein.  – James Lyons Weiler

Further, governments are bound by Pfizer’s lucrative but secret indemnification agreement for which they must:

  • acknowledge efficacy and risks are unknown
  • put up sovereign assets and military bases
  • promise to not penalize Pfizer for deliver delays
  • exempt Pfizer from all civil liability
  • pay for everything (all damages, lawsuits, losses, penalties, fines, settlements, attorney’s fees, costs and expenses)
  • not apply domestic laws to the company
  • protect Pfizer against intellectual property theft, while they are free to use anyone else’s intellectual property
  • keep everything a secret for 10 years

It’s crystal clear why our government is censoring, maligning, and denying effective treatments for COVID and pushing the need for a “shot in every arm.” They have nothing to lose (except lives) and everything to gain.  It’s also crystal clear why they downplay natural immunity, and the fact mortality from COVID is similar to the yearly flu.  These inconvenient facts would cause “vaccine” hesitancy, and they can’t have that.  Meanwhile, they completely ignore the vast devastation from lockdowns, fearmongering, and the “Fauci protocol.”

The following has billowed out (and continues to billow):

Vaccines are approved without proper safety studies, and nobody knows the effects of the cumulative effect of getting multiple vaccines. Many do not realize that Bill Gates, while pushing vaccines around the world that have caused hundreds of thousands of girls from India to be sterilized, doesn’t vaccinate his own children.

How many more whistleblowers will it take?  When will people realize we are in the biggest propaganda scheme in history?

For more:

Category:

Activism, Treatment, vaccines, Viruses

How Dr. Zelenko Bypassed the “HCQ Ban” to Beat COVID

https://plandemicseries.com/zstack/  Video Here  (Approx. 8 Min)

Dr. Zelenko has successfully treated more than 1,450 COVID-19 patients with a 99% success rate using a cocktail of hydroxychloroquine, Zinc Sulfate and Azithromycin.  Since the article in the link was written more than a year ago, the number of people he has treated is undoubtedly much higher.  Also, please note the video within the link has been scrubbed from the internet.  The ‘powers that be’ do not want you to know about successful, cheap, effective treatments.  They want you to take their dangerous, lucrative jab that is linked to more adverse events and death than any other vaccine in history, but they profit from.

Dr. Zelenko also helped author a 52 page COVID “Vaccine” Death report.

The video in the top link has important information to know, including Dr. Zelenko’s COVID protocol that you can obtain over the counter.  No prescription is needed.  Protocols below were derived from the video.  Dr. Zelenko was diagnosed with one of the rarest and most fatal cancers three years ago. 

For the countless lives he’s saved, he was nominated for the Noble Peace Prize.

For COVID prevention:

  • zinc 25 mg 1/day
  • vitamin C 1000 mg 1/day
  • D3 500 IU 1/day
  • Quercitin 500 mg 2/day

For COVID treatment:

  • zinc 50 mg 1/day for 7 days
  • vitamin C 1000 mg 1/day for 7 days
  • D3 5000 IU  1/day for 7 days
  • Quercetin 500 mg 2/day for 7 days

**Dr. Zelenko has developed and is selling a product with all the ingredients included for those who want it**

________________

For more:

Public health ‘authorities’, bought out scientists and science journals, mainstream and social media, medical groups and Big Pharma all have blood on their hands and should be held accountable for their “fake news” regarding HCQ, ivermectin, and vitamins  for treating COVID. These groups have rightly been called out for ‘fueling confusion and misinformation.”

You get the distinct impression they don’t want people to survive.

Similar to Lyme-land, real doctors are splitting away and forming their own alliances due to being hamstrung by regulators and hospitals literally killing people.

Current Government & Medical COVID policy = “get sicker,”and just take the jab already.

Category:

Activism, Supplements, Treatment, Viruses

New Guidance for Treatment of Lyme & Other TBD in Pregnancy

https://www.lymedisease.org/lyme-pregnancy-guidance/

New guidance for treatment of Lyme and other TBD in pregnancy

Oct. 27, 2021

from the Lyme Disease Association website:

In a recently published review article,* authors provide a comprehensive summary of treatment options for pregnant patients with less common bacterial, fungal, and viral infections, including several tick-borne diseases (Lyme disease, ehrlichiosis, human granulocytic anaplasmosis, human monocytic ehrlichiosis, babesiosis, and Rocky Mountain spotted fever).

This review provides guidance to clinicians based on the most recently published evidence-based research and expert recommendations.

The review included a search of MEDLINE (inception to March 2021); clinical practice guidelines (both national and international); the CDC website; and additional references from bibliographies of noteworthy articles. The review also provides a list of medications on the WHO Essential Medications List that are used to treat the above infections (*Alyssa P. Gould et al., Drugs in Context-peer reviewed).

A summary of key treatment recommendations from the review article for several tick-borne diseases during pregnancy are as follows:

Lyme disease:

  • Treatment of gestational Lyme disease is essential to reduce adverse outcomes in pregnancy. The data shows adverse outcomes in treated pregnancy is (11–16%) compared to untreated disease (50–60%).
  • Doxycycline should not routinely be used in pregnancy for Lyme disease in order to avoid adverse side effects including transient suppression of bone growth and staining of developing teeth, especially with proven alternatives.
  • Amoxicillin is the preferred treatment in the absence of neurological manifestations or atrioventricular heart block.
  • Ceftriaxone is typically reserved for patients with severe neurological or cardiac manifestations.
  • One study noted a non-significant increase in adverse pregnancy outcomes, such as pregnancy loss, among orally treated (31.6%) compared to parenterally treated (12.1%) pregnant patients.
  • Alternative oral therapy is cefuroxime axetil and parenteral therapies include penicillin G or cefotaxime.
  • Late Lyme disease (often manifesting as Lyme arthritis) may be managed with oral or parenteral β-lactams.

Ehrlichiosis & Anaplasmosis:

  • If infections with anaplasmosis or ehrlichiosis is suspected, treatment should be initiated due to the likelihood of complications and potential for vertical transmission of disease.
  • Rifampin has shown in vitro activity against ehrlichia and has been used successfully in limited case reports of pregnant women with anaplasmosis.
  • Doxycycline has been used successfully to treat ehrlichiosis.
  • Due to a lack of data, these pregnant patients should be closely monitored for resolution of disease.
  • The addition of amoxicillin or cefuroxime is suggested if coinfection with Lyme disease is suspected, as rifampin does not have activity against B. burgdorferi.

Babesiosis:

  • Patients with suspected babesiosis should be treated due to potential complications, including possible vertical transmission to the fetus.
  • Combination therapy is preferred with clindamycin plus quinine.
  • Longer treatment courses or retreatment may be needed in cases with symptoms and/or parasitaemia persisting >3 months. Resolution of parasitaemia should be used to determine treatment course.

Rocky Mountain spotted fever (RMSF):

  • RMSF cases are associated with poor outcomes for the fetus, regardless of the treatment.
  • Prevention is crucial for pregnant patients, and treatment should be provided within 3–5 days of exposure.
  • Doxycycline is the preferred therapy. Treatment course is typically 5–7 days or 3 days after fever resolution.
  • Chloramphenicol is a proposed alternative treatment; but there are concerns for significant adverse effects, including myelosuppression, aplastic anaemia, and grey baby syndrome, specifically at or near birth, and it is associated with higher mortality in RMSF. (chloramphenicol is not available orally in the US).

Read the full review article here.

Read other LDA articles regarding treatment here

Related posts:

  1. IDSA issues new, separate treatment guidelines for babesiosis
  2. TOUCHED BY LYME: CDC allows “possibility” of mother-fetus Lyme transmission
  3. Lyme Disease Co-Infections
  4. IDSA publishes new Lyme disease treatment guidelines

________________

**Comment**

Please remember there is great controversy in treating Lyme/MSIDS, even among experienced Lyme literate doctors.  There is quite a bit of trial and error involved as testing is so abysmal.  Wise clinicians diagnose and treat this clinically based upon symptoms, not solely upon testing.  Often, once treatment for Lyme starts and the pathogen load is reduced, other coinfections become noticeable requiring other medications.

For more:

Category:

Anaplasmosis, Babesia, Ehrlichiosis, Lyme, Pregnancy, Rocky Mountain Spotted Fever, Treatment

Latest ILADS 2021 Meeting

https://www.treatlyme.net/guide/fresh-ideas-from-2021-ilads  Video Here

The Latest from ILADS 2021 Annual Meeting

Here is the latest from ILADS 2021 Annual Meeting. During most ILADS annual meetings I find two or three new ideas I use in my treatments at Marty Ross MD Healing Arts. Watch the video clip in top link from my weekly Lyme Q&A webinar, Conversations with Marty Ross MD, for a full explanation of new insights and treatment ideas I learned this time.

  • Learn about lumbrokinase for Bartonella plaques and nests.
  • See how peptides, like BPC-157, could save the day.
Recommended Supplements

In the video I discuss lumbrokinase and BPC-157. Here is how I recommend using each of these supplements.

  • Lumbrokinase 20 mg, 1 pill 2 times a day. Do not take food, medicines or supplements beginning 1 hour before through 1 hour after taking.
  • Body Protection Compound (BPC-157) 500 mcg, 1 pill 2 times a day. Discuss using higher doses with your physician or health care provider.

You can find these products at Marty Ross MD Supplements.

See full profile: on LinkedIn
Follow: on Twitter, YouTube, and Instagram

About the Author

Marty Ross, MD is a passionate Lyme disease educator and clinical expert. He helps Lyme sufferers and their physicians see what really works based on his review of the science and extensive real-world experience. Dr. Ross is licensed to practice medicine in Washington State (License: MD00033296) where he has treated thousands of Lyme disease patients in his Seattle practice. 

Marty Ross, MD is a graduate of Indiana University School of Medicine and Georgetown University Family Medicine Residency. He is a member of the International Lyme and Associated Disease Society (ILADS) and The Institute for Functional Medicine.

________________

For more:

Category:

Bartonella, Lyme, Supplements, Treatment